(30 days)
The products found in the original 510(k) K950761, and K954417 will use the following Indications for Use:
- NonInfiammatory degenerative joint disease including osteoarthritis and avascular necrosis,
- Rheumatoid arthritis,
- Correction of functional deformity,
- Revision procedures where other treatments or devices have failed and
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head Involvement, unmanageable using other techniques.
For Cemented and Non-cemented use
The products found in the original 510(k) K920639, K920640 and K926107 will use the following Indications for Use:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
- Rheumatoid arthritis,
- Correction of functional deformity,
- Revision procedures where other treatments or devices have failed and
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
For Cemented use only
The products found in the original 510(k) K921274 will use the following Indications for Use:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
- Rheumatoid arthritis,
- Correction of functional deformity,
- Revision procedures where other treatments or devices have falled and
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
For Non-Cemented use only
The products found in the original 510(k) K970501 will use the following Indications for Use:
Intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses.
The device is a single use implant
Biomet's polyethylene components are manufactured from UHMWPE (GUR 1050) resin conforming to ASTM F-648, ISO 5834-1, and ISO 5834-2. This resin is isostatically compression molded under constant temperature and pressure and formed into acetabular components, which are designed to replace the articulating portion of the hip joint.
This document is a 510(k) summary for the Biomet ArCom® Polyethylene Liners and Components. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study for a novel device. Therefore, a direct answer to the request to describe acceptance criteria and a study proving a device meets these criteria in the context of AI/ML evaluation cannot be fully provided from the given text.
However, I can extract the relevant information from the document that pertains to how the device's equivalence and safety were established.
Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:
1. Table of acceptance criteria and the reported device performance:
This document is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices, not on setting new acceptance criteria and proving performance against them for a novel device. The "acceptance criteria" here would be demonstrating that the new device is as safe and effective as the predicate devices.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Non-Clinical Testing) |
|---|---|
| Material composition (UHMWPE GUR 1050 resin conforming to ASTM F-648, ISO 5834-1, and ISO 5834-2) is equivalent to or better than predicate device material (1900H). | The UHMWPE (GUR 1050) resin was confirmed to conform to ASTM F-648, ISO 5834-1, and ISO 5834-2. |
| Devices' technological characteristics (materials, design, sizing, and indications) are similar or identical to predicate devices. | Summarized as "similar or identical to the predicate device." |
| Performance in mechanical and aging tests meets or exceeds current standards/guidelines. | Process Validation: Tensile, impact, and physical properties met or exceeded current standards or guidelines. |
| Hip Simulator: Met or exceeded current standards or guidelines. | |
| Aging behavior: Met or exceeded current standards or guidelines. | |
| Shelf life: Met or exceeded current standards or guidelines. | |
| Indications for Use (IFU) are substantially equivalent to predicate devices. | The IFUs for the ArCom® Polyethylene Liners and Components (for various models and uses - cemented, non-cemented) were determined to be substantially equivalent to those of several predicate devices (K920640, K926107, K920639, K921274, K950761, K954417, K970501). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. No human "test set" data (clinical data) was used. The evaluation was primarily based on non-clinical (laboratory/mechanical) testing of the material.
- Data Provenance: The non-clinical testing was performed by Biomet, Inc. (Warsaw, IN, USA). This is laboratory/bench testing data, not human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "ground truth" establishment by experts in the context of clinical data was performed, as no clinical studies were submitted. Substantial equivalence relies on comparing the device's technical characteristics and non-clinical performance to legally marketed predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set data requiring adjudication was provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical medical implant (hip joint component) and not an AI/ML software. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this 510(k) context is the established safety and efficacy of the predicate devices and the conformity of the new device's material and performance to recognized standards and guidelines. For the non-clinical testing, the "ground truth" is based on the performance according to these established standards (ASTM F-648, ISO 5834-1, ISO 5834-2) and the results of the specific physical tests (tensile, impact, physical properties, hip simulator, aging behavior, shelf life).
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. Not an AI/ML algorithm.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.